Novo Nordisk A/S (NYSE:NVO) Q1 2023 Earnings Call Transcript

Lars Fruergaard Jorgensen: Thank you, Kerry. So I’ll give a shot on the first question on Wegovy. Then Martin, you can prepare for SELECT. I know it’s one of your favorite topics. So we have mentioned that we are reducing the starter doses in the coming months. So we’re not being very explicit on what that means, but it’s — we expect a limited period on this. And I don’t think we can get into quarter-by-quarter growth analysis. But of course, when you look at the TRx trend just the past few months here, there is a quite strong growth profile of that that will drive growth also in the coming quarters. And you can see our recent upgrade, which is taking this changed, say, availability of start doses into consideration that we see a very strong opportunity for sustaining growth.

With regards to launches outside of the U.S., we are eagerly interested in doing this gradual rollout also in more countries. We have seen a very strong uptake, both in Denmark and Norway. But it’s, of course, just like in the U.S., it’s important that we factor in capacity when we do these launches so we can sustainably supply patients. And I’ll not go into more specifics about what countries are next and when. There is some, say, competitive nature around that that I would like to keep for ourselves. Martin, on SELECT?

Martin Lange: Yes. So I’m the R&D guy, so when you ask me for what is hit for SELECT, I’ll only speak to it from a medical and scientific perspective. And in that respect, anything statistically significant makes sense. The primary endpoint is MACE. That’s MI. That’s stroke. That’s cardiovascular death. And saving a significant number of patients in that space is obviously a hit. Specifically for SELECT, we have designed with the power of detecting 17%. That is still our assumption. We have no new knowledge since we discussed this last. So the 17% would obviously be the perfect hit, but it could be plus/minus a few percent and still be highly statistically significant. So basically nothing new on that.

Lars Fruergaard Jorgensen: Thank you, Martin. And maybe I can add, say, a real-world data point because we have a lot of dialogue with healthcare systems, payers around the world, and many of them actually approach us with days as showing a correlation between high BMI and consumption of medical services. So of course, SELECT is important in establishing the health benefit of obesity intervention, but it’s actually already being acknowledged today. Those payers, those, say, integrated healthcare systems that have data on the population can see that high BMI leads to higher consumption of healthcare services. So I believe antiobesity medicine has the opportunity of establishing itself as one of the best, say, investment cases for healthcare systems when it comes to actually addressing this chronic disease. Thank you, Kerry. And next set of question please?

Operator: Thank you. We will take our next question. Please stand by. Your next question comes from the line of Sachin Jain from Bank of America Please ask your question.

Sachin Jain: Thanks for taking my questions. Two, if I may. So earlier, you mentioned the stable GLP-1 pricing environment. Payer debates on GLP-1 and diabetes and obesity have come up on a number of pay accruals. So just wondering if you’re picking up any pressure in your sort of conversations on attempts to restrict off-label usage and the telehealth phenomenon that’s obviously across all of the press. And perhaps, can you just update us on what percentage of Wegovy you see as cash usage and the average BMI of Wegovy usage, that would just be helpful, I think, to comfort investors around the off-label. Secondly, for Karsten, just obviously big upgrading guide. Any color on what fading GLP-1 market growth when Wegovy trends are assumed in the top end of guide?

I just wondered if you could update us on the Wegovy bolus discussion from back at full year, which doesn’t seem to be correct, and it doesn’t really feel like that your top end of guidance is assuming a continuation of this 50% market growth rate. And then if I may, can I just add one clarification to Richard’s prior question? If Wegovy flatlined and Ozempic/Saxenda inflect, can you supply that inflection? Thank you.

Lars Fruergaard Jorgensen: Thank you. Sachin. I think we’ll go to you first, Doug, on how you’re seeing the U.S. payer focus on GLP-1 pricing and if you could also give a perspective on what you see of Wegovy profile cash/on formulary insurance and also BMI profile of those we treat. And then, Karsten, there were some questions on what we have assumed in the guidance and also product mix. Over to your first, Doug.

Doug Langa: Yes. Thank you, Sachin. Thank you, Lars. So I think it’s first important to note that we continue to see very strong access for Wegovy. We have over 40 million lives today that includes all major PBMs. I think it’s also normal to see, as you see increasing focus and pressure on products that have volumes going up, and that’s in any category, including this one, which continues to add controls to those products. So I think that’s just important. As far as the question around cash, we see it about 5% to 10%. But also importantly, we see over 80% of our patients today pay $25 or less. So I think that’s important to note.

Lars Fruergaard Jorgensen: Thanks, Doug. Any — do you have any data on the BMI for those who are on treatment?

Doug Langa: I’m sorry. Yes, it’s about 38 here in the U.S., BMI, Yes.

Lars Fruergaard Jorgensen: So very, very high BMI. I think that’s — those are encouraging data, both in terms of the type of payer profile and BMI. And, Karsten, on some of the assumptions?

Karsten Munk Knudsen: Yes. So of course, when we build our guidance, then we’re looking at the most recent data points in our trending. And the big movers in terms of sales growth for the company this year is clearly Ozempic and Wegovy. I wouldn’t go into the details on what exact assumptions we have because, as you know, market growth is a function of competition, payers, prescribers, etc., and supplies. And I would say that when we did the Wegovy forecast for our guidance, we did anticipate a slowdown in TRx growth, and we have been out saying that we would not be able to supply to a continuation of the trends we saw in the first month of the year. So guidance-wise, there’s no big surprise in a bending curve for Wegovy in terms of the mathematics.

Ozempic, yes, we put an assumption in, which, of course, is linked to the oral trending in the market and supply situation. And as I said in my first commentary around the top end of the guidance, then the key point is that it’s not — 30% is not a hard ceiling, but we are getting closer to our capacity limitations as evidenced by the drug shortage notifications and the reduction in low-dose strengths for Wegovy.

Lars Fruergaard Jorgensen: Thank you, Karsten. Thank you, Doug. Thank you, Sachin.

Sachin Jain: Sorry, there was the Ozempic/Saxenda supply inflection question if Wegovy flatlined. I don’t know whether you can address that.

Karsten Munk Knudsen: I think, Doug, if you could speak to the Wegovy/Ozempic. But if I start out, then I would say for any spill or consequences from the reduction in low-dose strengths of Wegovy, then the key point is that a big part of the patients getting Wegovy, they actually seek Wegovy when they get to the physician and get the script. And we’re not out of the market with the low-dose strengths. We’re just reducing supply. So I would balance your question by saying that probably a lot of the patients, say, they will be getting the product, there might just be a delay in terms of when the script is being filled at pharmacy. I don’t know, Doug, if you have more to add to that.

Doug Langa: Karsten, what I would just add is that, overall, and Camilla mentioned it earlier, that diabetes has still an overall lower GLP-1 penetration rate. And then secondly, we expect continued strong demand for our GLP-1 products. We have strong demand now, and we continue — and we expect continued demand.

Lars Fruergaard Jorgensen: Thank you. We have time for one quick final round of questions.

Operator: Of course. Please stand by. Your next question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead. Your line is open.

Mark Purcell: Yes. Thank you very much for squeezing me in. Two questions. On your pill pass oral GLP-1, so you’ve obviously solved the clinical challenge, but not the COGS challenge yet. So should we expect you to achieve small molecule like COGS with your STACK technology? And can you provide some perspective on whether you would seek to develop a small molecule on asset as an insurance policy? And then secondly, in terms of the GLP-1 supply full and finish, that whole topic, where are you in terms of being able to meet demand for Ozempic in international markets where penetration rates are so much lower? And can you give us some insurance in terms of how you’re building the supply chain behind CagriSema when it comes to a more complex device than the fill and finish behind that? Thank you.